Senior Batch Record Specialist | Senior Batch Record (w/m/d)

Job Summary

This Senior Batch Record Specialist role involves ensuring strict compliance with Good Manufacturing Practice (GMP) guidelines during the review and processing of batch documentation. Day-to-day tasks include checking Manufacturing Instructions (HABs), coordinating timely corrections, and supporting GMP audits and inspections. A key part of the role is creating and revising documentation-relevant Standard Operating Procedures (SOPs) and conducting necessary training. The specialist will also electronically capture and analyze batch data to identify process optimization potential, coordinate across departments to reduce backlogs, and contribute to the introduction of new Electronic Batch Record (EBR) systems. This position is ideal for experienced professionals with a Master's degree in Biotechnology and deep knowledge of pharmaceutical manufacturing and regulatory requirements, offering an opportunity to drive process improvement in a dynamic environment.